Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial.
Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial.
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DOI：
10.1093/jpids/piv041
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发表时间：
2016-06
影响因子：
3.2
通讯作者：
Jain VK
中科院分区：
文献类型：
--
作者：
Wang L;Chandrasekaran V;Domachowske JB;Li P;Innis BL;Jain VK
来自两种乙型流感谱系的病毒共循环，导致三价流感疫苗（TIV）的保护效果欠佳。含有两种谱系的四价流感疫苗（QIV）提供更广泛的保护。我们在美国6-35月龄儿童（标识符NCT01974895）的II期随机（1:1）观察盲试验中比较了灭活的季节性QIV和TIV（每种流感毒株分别为15和7.5 μg血凝素[HA]）。主要目的是在疫苗接种完成后28天评估QIV对4种疫苗株的免疫应答。次要目的是证明QIV与TIV相比，QIV中含有的B/Victoria菌株具有优势，而TIV中没有。在按方案队列中评估免疫原性（N = 280），在意向治疗队列中评估安全性（N = 314）。A/H1N1、A/H3N2、B/Yamagata和B/Victoria的QIV血清转化率（SCRs）分别为80.4%（95%可信区间[CI]， 73.0% ~ 86.6%）、72.0% （95% CI, 63.9% ~ 79.2%）、86.0% （95% CI, 79.2% ~ 91.2%）和66.4% （95% CI, 58.1% ~ 74.1%）。四价流感疫苗对B/Victoria的免疫原性优于TIV，几何平均滴度比为4.73 (95% CI, 3.73%-5.99%)， SCR差异为54.02% （95% CI, 43.88%-62.87%）。尽管QIV的抗原含量较高，但两组疫苗的安全性相似。未报告与疫苗接种相关的严重不良事件。四价流感疫苗（15µg HA/株）具有免疫原性，具有可接受的安全性。该药物在6-35个月大儿童中的下一阶段开发是在尚未获得许可的国家进行三期试验。在已经获得许可的国家，从TIV转向QIV将为这一弱势群体提供更广泛的保护。
Viruses from 2 influenza B lineages co-circulate, leading to suboptimal protection with trivalent influenza vaccines (TIV). Quadrivalent influenza vaccines (QIV) containing both lineages offer broader protection. We compared inactivated seasonal QIV versus TIV (15 and 7.5 μg hemagglutinin [HA] for each influenza strain, respectively) in a phase II randomized (1 : 1), observer-blind trial in US children 6–35 months of age (identifier NCT01974895). The primary objective was to evaluate immune responses induced by QIV for the 4 vaccine strains 28 days after completion of vaccination. A secondary objective was to demonstrate superiority of QIV versus TIV for the B/Victoria strain contained in QIV but not TIV. Immunogenicity was evaluated in the per-protocol cohort (N = 280), and safety was evaluated in the intent-to-treat cohort (N = 314). Seroconversion rates (SCRs) for QIV were 80.4% (95% confidence interval [CI], 73.0%–86.6%), 72.0% (95% CI, 63.9%–79.2%), 86.0% (95% CI, 79.2%–91.2%), and 66.4% (95% CI, 58.1%–74.1%) for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria, respectively. Quadrivalent influenza vaccines demonstrated immunogenic superiority over TIV for B/Victoria with a geometric mean titer ratio of 4.73 (95% CI, 3.73%–5.99%) and SCR difference of 54.02% (95% CI, 43.88%–62.87%). Safety was similar between the vaccine groups despite the QIV's higher antigen content. No serious adverse events were reported related to vaccination. Quadrivalent influenza vaccine (15 µg HA/strain) was immunogenic with an acceptable safety profile. The next phase of its development in children 6–35 months of age is a phase III trial in countries where it is not yet licensed. In countries where it is already licensed, a switch from TIV to QIV would provide broader protection in this vulnerable group.